News

InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
BioPharma Dive8m
Roche stops shipping Sarepta gene therapy in some countries outside US
The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in ...
Fierce Pharma1h
Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
Sarepta's licensing partner Arrowhead expects near-term payments despite setbacks
Sarepta Therapeutics' licensing partner Arrowhead Pharmaceuticals said on Wednesday it expects to receive near-term milestone ...
Arrowhead Pharma (ARWR) Shares Dragged by Sarepta Concerns
We recently published 10 Big Names Get Slammed. Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) is one of the biggest losers on ...
Sarepta falls after gene therapy maker pauses Elevidys shipments in US
Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...
STAT21h
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.
Fierce Biotech2h
With $550M on the line, Arrowhead reassures investors about pact with troubled Sarepta
Arrowhead Pharmaceuticals has moved to reassure Wall Street about its deal with Sarepta Therapeutics, telling investors that ...
BioSpace5h
Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...
STAT3h
Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more
Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the ...
Roche pauses Sarepta gene therapy shipments outside the U.S.
Roche (OTCQX:RHHBY) has decided to pause overseas shipments of Elevidys gene therapy developed by Sarepta Therapeutics ...